BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    HYALEX ORTHOPAEDICS

    · Expires 2026
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    HYALEX ORTHOPAEDICS
    Status
    Inactive
    Expiry Year
    2026
    Initial Importer
    No
    Address
    99 Hayden Ave Bldg D Ste 340
    City
    Lexington
    State
    MA
    ZIP
    02421
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250074

    Owner / Operator

    Firm Name
    Hyalex Orthopaedics
    Operator Number
    10095924
    Address
    99 Hayden Blvd., Bldg. D, Ste. 340
    City
    Lexington
    State
    MA
    Postal Code
    02421
    Country
    US
    Correspondent
    Christopher Cain

    Products

    Device Name Product Code
    Prosthesis, Toe, Hemi-, Phalangeal KWD

    Proprietary Names

    HYALEX Slalom MTP Hemiarthroplasty Implant

    Establishment Types

    Manufacture Medical Device